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20.06.2017 | Original Article

Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG)

verfasst von: Yasuhiro Miyake, Junichi Nishimura, Takeshi Kato, Masataka Ikeda, Masaki Tsujie, Taishi Hata, Ichiro Takemasa, Tsunekazu Mizushima, Hirofumi Yamamoto, Mitsugu Sekimoto, Riichiro Nezu, Yuichiro Doki, Masaki Mori, Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)

Erschienen in: Surgery Today | Ausgabe 1/2018

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Abstract

Purpose

Oral adjuvant uracil and tegafur plus leucovorin (UFT/LV) is not inferior to standard weekly fluorouracil and folinate for stage II/III colon cancer. However, protein-bound polysaccharide K (PSK) has been evaluated as postoperative adjuvant therapy for colorectal cancer. This report is the first of MCSGO-CCTG, which compared UFT/LV to UFT/PSK as adjuvant chemotherapy for stage IIB or III colorectal cancer in patients who had undergone Japanese D2/D3 lymph node dissection.

Methods

The primary endpoint was the 3-year disease-free survival (DFS). A randomized non-inferiority study compared UFT/LV to UFT/PSK. The overall survival, adverse events, compliance, and quality of life were also investigated as the secondary endpoints.

Results

Between March 2006 and December 2010, 357 patients were randomized to UFT/PSK (n = 178) or UFT/LV (n = 179) (median age 65 years, colon/rectum 67.4/32.6%, stage IIB/IIIA/IIIB/IIIC 11.1/15.7/55.0/18.2%). The 3-year DFS rate was 82.3% in those receiving UFT/LV and 72.1% in those receiving UFT/PSK. The non-inferiority of UFT/PSK adjuvant therapy to UFT/LV therapy was not verified (−9.06%, 90% confidence interval −17.06 to −1.06%). The 3-year overall survival rate was 95.4% in those receiving UFT/LV and 90.7% in those receiving UFT/PSK.

Conclusions

As adjuvant chemotherapy for stage IIB and III colorectal cancer patients, UFT/PSK adjuvant therapy was not non-inferior to UFT/LV therapy with respect to the DFS.

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Titel: Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG)
verfasst von: Yasuhiro Miyake
Junichi Nishimura
Takeshi Kato
Masataka Ikeda
Masaki Tsujie
Taishi Hata
Ichiro Takemasa
Tsunekazu Mizushima
Hirofumi Yamamoto
Mitsugu Sekimoto
Riichiro Nezu
Yuichiro Doki
Masaki Mori
Multi-center Clinical Study Group of Osaka, Colorectal Cancer Treatment Group (MCSGO)
Publikationsdatum: 20.06.2017
Verlag: Springer Japan
Erschienen in: Surgery Today / Ausgabe 1/2018
Print ISSN: 0941-1291
Elektronische ISSN: 1436-2813
DOI: https://doi.org/10.1007/s00595-017-1555-1

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